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PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT02730312
Recruitment Status : Recruiting
First Posted : April 6, 2016
Last Update Posted : August 6, 2021
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Xencor, Inc.

Study Description
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Brief Summary:
The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia B-cell Acute Lymphoblastic Leukemia Blastic Plasmacytoid Dendritic Cell Neoplasm Chronic Myeloid Leukemia, Blast Crisis Biological: XmAb14045 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®14045 in Patients With CD123-Expressing Hematologic Malignancies
Actual Study Start Date : August 2016
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: XmAb14045
Biological/Vaccine: XmAb14045 Administered IV weekly up to 8 weeks
 Biological: XmAb14045
Administered IV weekly up to 8 weeks, with or without step-up dosing


Outcome Measures
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Primary Outcome Measures :
  1. Safety as determined by the number of participants with treatment-related adverse events [ Time Frame: Baseline Day 1 through Day 56 ]
    Treatment-related adverse events as assessed by CTCAE v4.03

  2. Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing [ Time Frame: Baseline Day 1 through Day 56 ]
    Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of 1 of the following diseases:

    • Primary or secondary AML (including erythroleukemia and eosinophilic leukemia, but excluding acute promyelocytic leukemia)
    • B-cell ALL
    • BPDCN
    • CML in blast phase, resistant or intolerant to tyrosine kinase inhibitor therapy
  • Patients with relapsed or refractory disease with no available standard therapy
  • ECOG performance status 0-2
  • Not a candidate for, or refusing treatment with hematopoietic stem cell transplantation
  • Fertile patients must agree to use effective contraception during and for 4 weeks after the last dose of XmAb14045
  • Male patients must agree to use highly effective contraception, and refrain from donating sperm during the treatment period and for at least 4 weeks after the last dose of XmAb14045
  • Able and willing to complete the entire study

Exclusion Criteria:

  • Systemic antineoplastic therapy (including cytotoxic chemotherapy and toxin immunoconjugates, but excluding hydroxyurea), unconjugated antibody therapy, or radiotherapy within 2 weeks of the first dose of study treatment, or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
  • Prior therapy with CD123- or IL-3R-directed immunotherapies, including monospecific and bsAbs, immunoconjugates, or chimeric antigen receptor- modified T-cell therapy
  • Failure to recover from Grade 3 or 4 toxicity from previous treatment (unrelated to malignant bone marrow involvement)
  • Known uncontrolled central nervous system involvement by malignant disease
  • Absolute blast count ≥10,000/mm3 or symptoms of leukostasis
  • Diagnosis of promyelocytic leukemia
  • Aspartate aminotransferase or alanine aminotransferase at screening >3.0 x upper limit of normal (ULN) unless considered due to leukemic organ involvement
  • Bilirubin >1.5 x ULN, unless prior diagnosis and documentation of leukemic organ involvement, ongoing hemolysis, or Gilbert's syndrome
  • Serum creatinine >2.0 x ULN, or estimated creatinine clearance <40mL/min
  • Active heart failure or New York Heart Association Class III or IV or Objective Assessment C or D
  • History or evidence of a clinically unstable/uncontrollable disorder, condition or disease other than primary malignancy, that in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures, or completion
  • Evidence of any active, uncontrolled bacterial, viral, parasitic, or systemic fungal infections within 1 week of first dose of study drug
  • Positive test for human immunodeficiency virus (HIV) -I or -II antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody (unless HCV viral load test by PCR is negative). HBcAb positivity will be allowed if one or more of the following is true: a) HBsAb is present; b) hepatitis B DNA testing is negative and the patient is receiving hepatitis B reactivation prophylaxis with entecavir, tenofovir, or lamivudine
  • Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the End of Study visit
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730312


Contacts
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Contact: Raman Garcha, MD 858-775-5091 rgarcha@xencor.com
Contact: Chelsea Johnson, RN 858-480-3891 cjohnson@xencor.com

Locations
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United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: James M Foran, MD         
United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: William Blum, MD         
Winship Cancer Institute, Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: William Blum, MD         
Blood and Marrow Transplant Group of Georgia Recruiting
Atlanta, Georgia, United States, 30342
Contact: Asad Bashey, MD, PhD         
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Asad Bashey, MD, PhD         
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Wendy Stock, MD       wstock@medicine.bsd.uchicago.edu   
United States, Ohio
Wexner Medical Center at The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Alice Mims, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Farhad Ravandi-Kashani, MD       fravandi@mdanderson.org   
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Raya Mawad, MD         
Sponsors and Collaborators
Xencor, Inc.
ICON Clinical Research
Investigators
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Study Director: Raman Garcha, MD Xencor, Inc.
More Information
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Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT02730312    
Other Study ID Numbers: XmAb14045-01
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xencor, Inc.:
AML
B-ALL
BPDCN
CML
Blast Crisis
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Neoplasms
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Blast Crisis
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid
Neoplasms by Site
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Cell Transformation, Neoplastic
Carcinogenesis
Neoplastic Processes
Pathologic Processes